Clinical research associate jobs in Nipomo, CA

We are seeking a PhD-level Clinical Scientist to support the Biologics License Application (BLA) submission for a Breakthrough Therapy-designated biologic targeting a neurodegenerative rare disease. This role will contribute to late-stage clinical development, supporting clinical data interpretation, regulatory documentation, and cross-functional collaboration as the program advances toward potential approval. Key Responsibilities Support late-stage clinical development and BLA submission activities Interpret and synthesize clinical efficacy, safety, and biomarker data in pediatric populations Author and review clinical sections of regulatory documents (Modules 2 and 5) Collaborate cross-functionally with Regulatory, Clinical Operations, Biostatistics, and Medical Affairs Support FDA interactions and regulatory meetings as needed Qualifications PhD in a life sciences discipline 5+ years of clinical development experience in biotech or pharma Experience supporting late-stage programs and regulatory submissions (BLA/NDA/MAA) Strong scientific writing and cross-functional collaboration skills Experience in rare disease, pediatric, neurodegenerative, or biologics programs preferred Why This Role This is an opportunity to contribute to a Breakthrough Therapy-designated biologic at a critical regulatory milestone, advancing a program aimed at addressing serious unmet need in pediatric neurodegenerative disease.

You will be responsible for scientific oversight, data integrity and quality of clinical trial(s) in support of the development strategy for programs within our Late-Stage Oncology portfolio. **Clinical development expert for assigned studies maintaining current scientific and clinical knowledge in the specific therapeutic and disease area(s) of assignment. Effectively partner with other clinical and medical colleagues, clinical operations and other functional lines for the successful implementation and execution of the clinical trial(s) within the assigned program. Responsible for scientific oversight, data integrity and quality of the clinical trial(s). Represent the study team in governance meetings and submissions, partners with/supports the Development lead/Medical Director regarding study and disease area strategy. Author protocols, study level informed consent documents, and contributes to authoring of IBs, site training materials, clinical study reports, regulatory responses, and other clinical and regulatory documents; supports preparations for Health Authority meetings, participates as appropriate. Set the clinical data review strategy and leads the team in the collection of quality data and review of emerging clinical data and trends; reviews and queries data; presents and discusses relevant data to appropriate teams, governance bodies, and other internal and external stakeholders. In close partnership with medically qualified colleague/s, analyze the emerging safety profile of the drug, keeping the clinical and safety colleagues informed of changes in the safety profile as they occur in the assigned trial(s). Follow relevant SOPs and regulations, has an excellent understanding of and complies with applicable trainings, seeks opportunities to further improve quality and efficiency of clinical procedures; PhD/Pharm D in a relevant Science discipline and minimum of 5 years Clinical Research experience in industry/CRO, **OR** MS in a relevant Science discipline and minimum of 7 years of Clinical Research experience in industry/CRO **OR** BA/BS in a relevant Science discipline and minimum of 10 years Clinical Research experience in a similar role in industry/CRO Clinical Research experience in the phase 2 - 3/pivotal space in Oncology, ideally on the side of the sponsor and with a track record of successful regulatory submission, inspection, and regulatory approval Clinical Operations, Safety, Biostatistics, Regulatory, Study Management, Pre-clinical, Pharmacology, Quality Assurance Experience working on large data sets Proficiency with Microsoft Office and relevant scientific software Track record of scientific productivity as evidenced by publications, posters, abstracts and/or presentations Experience building partnerships across the company to achieve the needs of the program **Demonstrates passion for helping patients with cancer and for the science of oncology Flexibility to adapt and navigate through an ever-changing work environment while maintaining integrity and quality in the work assigned Demonstrates autonomous delivery, problem-solving, and agile decision-making in execution of Clinical responsibilities Promotes team health and exemplifies Pfizer's leadership behaviors and actionable attitudes Leverages knowledge and support from others related to overall objectives, strategy, critical issues, and policies Promotes innovation and takes appropriate risks to challenge the status quo in order to enhance the efficiency of current processes Embraces evolving technologies and adopts best practices aimed at improving the efficiency and quality of clinical development Works well in a diverse team environment with colleagues from diverse cultures, backgrounds, and geographies. Work Location Assignment:** This is a hybrid role requiring you to live within commuting distance and work on-site an average of 2.5 days per week In addition, this position is eligible for participation in Pfizer's Global Performance Plan with a bonus target of 20.0% of the base salary and eligibility to participate in our share based long term incentive program. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of life's moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution, paid vacation, holiday and personal days, paid caregiver/parental and medical leave, and health benefits to include medical, prescription drug, dental and vision coverage. Learn more at Pfizer Candidate Site - U.Pfizer compensation structures and benefit packages are aligned based on the location of hire. Relocation assistance may be available based on business needs and/or eligibility. **Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This position requires permanent work authorization in the United States. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process and/or interviewing, please email disabilityrecruitment@pfizer.This is to be used solely for accommodation requests with respect to the accessibility of our website, online application process and/or interviewing. Medical

Clinical Research Coordinator (Oncology) Duration: 6-month Contract to Hire About the Role: We are seeking an experienced Clinical Research Coordinator (CRC) to support active oncology clinical trials at hospital-based research sites in California. This is a hands-on, fully onsite role supporting patient-facing research activities from study start-up through close-out. This is a net-new, urgent opening with a strong likelihood of extension and potential conversion to a full-time role. What You'll Be Doing: Coordinate and execute oncology clinical trials under the direction of Principal Investigators Recruit, screen, consent, and enroll research participants Coordinate and conduct protocol-required visits, procedures, labs, and assessments Collect, enter, and report study data per protocol and sponsor requirements Process, handle, and ship biological specimens in accordance with federal regulations Support study drug accountability and coordinate medication administration Identify and report adverse events, SAEs, protocol deviations, and violations Participate in sponsor monitoring visits, audits, and inspections Serve as a liaison between patients, investigators, sponsors, IRBs, and clinical teams Maintain inspection and audit readiness across studies Required Qualifications: 3+ years of experience as a Clinical Research Coordinator At least 1 year of oncology clinical trial experience Experience serving as primary CRC on multiple drug and/or device trials Strong patient-facing experience in a healthcare or research setting Bachelor's degree in a science or related field (or equivalent experience) Experience with EDC systems and CTMS platforms Ability and willingness to work fully onsite Certifications: Willingness to obtain one of the following within 12 months: CCRP (SOCRA) CCRC (ACRP or SCRA) Certified Phlebotomy Technician (ANCC) Additional Details: Full-time, onsite schedule Equipment provided EHR: Cerner Interview process includes one virtual interview and one onsite interview

Senior Clinical Research Coordinator Full-Time - Day Shift Advance the Future of Clinical Research Are you passionate about clinical research and ready to take your expertise to the next level? At University Health, we're seeking a Senior Clinical Research Coordinator to lead and support high-impact studies that shape the future of patient care. This is a unique opportunity to bring your clinical insight and research experience to a role that supports innovation, compliance, and excellence in human subject research. What You'll Do As a Senior Clinical Research Coordinator , you'll play a vital leadership role in the coordination and review of complex human subject research protocols. You will: Evaluate and provide expert clinical and risk assessment on research protocols and procedures Assist the Director with implementing a robust Human Subjects Protection Program Serve as a departmental representative to internal and external research committees, including IRB and OHRP Coordinate, monitor, and educate staff on best practices in research compliance and study execution Support grant applications, budgeting, and program planning across diverse research initiatives What We're Looking For Education & Experience: Required: Bachelor's of Science in Nursing (BSN) from an accredited institution Minimum 3 years of clinical research experience Working knowledge of research methods and federal regulations for human subject research Must possess or qualify to obtain CCRP or CCRA certification within 6 months of hire Core Competencies: Strong leadership and judgment in confidential, regulatory, and ethical matters Ability to navigate complex research protocols with a sharp eye for detail Confident representing the department in multi-institutional settings Excellent communication, planning, and coordination skills Why Join Us? At University Health, you'll be part of a team that is passionate about research, innovation, and improving patient outcomes. We offer: A dynamic, collaborative, and mission-driven environment Opportunities to lead and influence policy at the institutional and national levels A commitment to professional development and clinical research excellence The chance to make a real impact on groundbreaking studies and healthcare transformation Ready to Elevate Clinical Research? Bring your skills, passion, and vision to a team that's shaping the future of healthcare research. Apply today to become our Senior Clinical Research Coordinator.

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Discovery & Pre-Clinical/Clinical Development Job Sub Function: Clinical Development & Research - Non-MD Job Category: Scientific/Technology All Job Posting Locations: Irvine, California, United States of America, Milpitas, California, United States of America Job Description: About Vision Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding on the possibilities of vision treatments? Ready to join a team that's reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs - from the pediatric to aging eye - in a patient's lifetime. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech We are searching for the best talent for a Principal Clinical Research Scientist - Equipment Platform Vision. The role is based on either the Irvine, CA or Milpitas, CA campuses. Purpose: The Principal Clinical Research Scientist - Equipment Platform Vision is an expert in ophthalmic and medical device research who is a core team member on key projects. Your insights will drive the strategic direction for crafting clinical programs that generate scientific evidence to bring new technologies to eye care professionals and their patients. You should have an in-depth understanding of clinical research (science and execution), as well as familiarity with new product development, design control, and ophthalmic device regulations. A good grasp of related healthcare markets and clinical trends is also beneficial. You demonstrate a consistent track record as a key leader and contributor in complex projects, who delivers as promised. Be able to independently build collaborative relationships, influence and align with your functional partners, prioritize multiple projects, and delegate when efficient. You will be responsible for: Represent Clinical Science as core team member on critical projects, liaising between project and functional teams, and coordinating with Clinical Operations and Project Management partners to deliver on time, within budget, and in compliance with regulations and SOPs Activate and build collaborative relationships with across business platforms as well as key cross-functional partners (e.g., Global Strategic Marketing, Medical Affairs, Regulatory Affairs, R&D, etc.) to ensure consistent alignment in new product development and through product life cycle Lead initiatives for appropriate interpretation and dissemination of all evidence generated, including Clinical Study Reports, abstracts, manuscripts, and MDR-related documents (CER, PMCF, Clinical Plans, etc.) Contribute to clinical scientific discussions with regulatory agencies that support the clinical and regulatory strategy, including proposed investigations, review process of evidence to support marketing authorization, and support of regulatory inspections Engage and collaborate with industry's key opinion leaders, including KOLs and regulatory agencies, and build on relationships established through professional/technical societies Performs other related duties as assigned by management Qualifications An advanced degree in a Scientific Field is required. A Doctoral Degree-Optometry or MD with specialty in Ophthalmology is highly recommend. Other: Post-graduate degree or residency is preferred Minimum of 8 years of relevant clinical / scientific work experience, including leadership functions (ie. leading or mentoring teams, non-managerial leadership experiences) is required Experience in software-driven medical devices and capital equipment is preferred Strong technical writing ability, such as clinical study protocols, reports and abstracts is required Understanding of biostatistics as applied to study data is required Proficient with computers and software programs is required Ability to travel 10% of the time is required. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource. #LI-VY1 #LI-Hybrid Required Skills: Preferred Skills: Clinical Evaluations, Coaching, Critical Thinking, Drug Discovery Development, Entrepreneurship, Good Clinical Practice (GCP), Leadership, Medicines and Device Development and Regulation, Organizing, Regulatory Affairs Management, Relationship Building, Research Documents, Safety-Oriented, Scientific Research, Standard Scientific Processes and Procedures, Strategic Change, Study Management The anticipated base pay range for this position is : $134,000.00 - $231,150.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave - 80 hours in a 52-week rolling period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at ******************* Job Function: Discovery & Pre-Clinical/Clinical Development Job Sub Function: Clinical Development & Research - Non-MD Job Category: Scientific/Technology All Job Posting Locations: Irvine, California, United States of America, Milpitas, California, United States of America Job Description: About Vision Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding on the possibilities of vision treatments? Ready to join a team that's reimagining how vision is improved? Our Vision team solves the toughest health challenges. Help combine cutting-edge insights, science, technology, and people to encourage eye care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs - from the pediatric to aging eye - in a patient's lifetime. Your unique talents will help patients on their journey to wellness. Learn more at *******************/medtech We are searching for the best talent for a Principal Clinical Research Scientist - Equipment Platform Vision. The role is based on either the Irvine, CA or Milpitas, CA campuses. Purpose: The Principal Clinical Research Scientist - Equipment Platform Vision is an expert in ophthalmic and medical device research who is a core team member on key projects. Your insights will drive the strategic direction for crafting clinical programs that generate scientific evidence to bring new technologies to eye care professionals and their patients. You should have an in-depth understanding of clinical research (science and execution), as well as familiarity with new product development, design control, and ophthalmic device regulations. A good grasp of related healthcare markets and clinical trends is also beneficial. You demonstrate a consistent track record as a key leader and contributor in complex projects, who delivers as promised. Be able to independently build collaborative relationships, influence and align with your functional partners, prioritize multiple projects, and delegate when efficient. You will be responsible for: Represent Clinical Science as core team member on critical projects, liaising between project and functional teams, and coordinating with Clinical Operations and Project Management partners to deliver on time, within budget, and in compliance with regulations and SOPs Activate and build collaborative relationships with across business platforms as well as key cross-functional partners (e.g., Global Strategic Marketing, Medical Affairs, Regulatory Affairs, R&D, etc.) to ensure consistent alignment in new product development and through product life cycle Lead initiatives for appropriate interpretation and dissemination of all evidence generated, including Clinical Study Reports, abstracts, manuscripts, and MDR-related documents (CER, PMCF, Clinical Plans, etc.) Contribute to clinical scientific discussions with regulatory agencies that support the clinical and regulatory strategy, including proposed investigations, review process of evidence to support marketing authorization, and support of regulatory inspections Engage and collaborate with industry's key opinion leaders, including KOLs and regulatory agencies, and build on relationships established through professional/technical societies Performs other related duties as assigned by management Qualifications An advanced degree in a Scientific Field is required. A Doctoral Degree-Optometry or MD with specialty in Ophthalmology is highly recommend. Other: Post-graduate degree or residency is preferred Minimum of 8 years of relevant clinical / scientific work experience, including leadership functions (ie. leading or mentoring teams, non-managerial leadership experiences) is required Experience in software-driven medical devices and capital equipment is preferred Strong technical writing ability, such as clinical study protocols, reports and abstracts is required Understanding of biostatistics as applied to study data is required Proficient with computers and software programs is required Ability to travel 10% of the time is required. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please contact us via *******************/contact-us/careers or contact AskGS to be directed to your accommodation resource. #LI-VY1 #LI-Hybrid Required Skills: Preferred Skills: Clinical Evaluations, Coaching, Critical Thinking, Drug Discovery Development, Entrepreneurship, Good Clinical Practice (GCP), Leadership, Medicines and Device Development and Regulation, Organizing, Regulatory Affairs Management, Relationship Building, Research Documents, Safety-Oriented, Scientific Research, Standard Scientific Processes and Procedures, Strategic Change, Study Management The anticipated base pay range for this position is : $134,000.00 - $231,150.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation -120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year Holiday pay, including Floating Holidays -13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave - 80 hours in a 52-week rolling period10 days Volunteer Leave - 32 hours per calendar year Military Spouse Time-Off - 80 hours per calendar year

General Information Press space or enter keys to toggle section visibility Onsite or Remote Flexible Hybrid Work Schedule Monday - Friday, 8:00am - 5:00pm Posted Date 12/03/2025 Salary Range: $82705.68 - 133068.24 Annually Employment Type 2 - Staff: Career Duration Indefinite Job # 27681 Primary Duties and Responsibilities Press space or enter keys to toggle section visibility The Senior Clinical Research Coordinator plays a critical role in the overall operational management of clinical research/trial/study activities from design, set up, conduct, through closeout. The ideal candidate is an experienced professional or leader who has direct responsibility for the implementation of research activities for one or more studies which may include multicenter clinical trials (both NIH and industry-sponsored), local investigator-initiated clinical trials, and/or programmatic clinical research activities. Recognize and perform necessary project management tasks and prioritizes work to reach scheduled goals. The Senior Clinical Research Coordinator is a technical leader responsible for ensuring the study protocol and procedures have been completed accurately, safely, and in a timely manner. This position may supervise and train others on projects as necessary. Work with PIs, departments, sponsors, institutions, and other entities as needed to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of studies. Annual salary range: $86,849.29 - $139,713.11 Job Qualifications Press space or enter keys to toggle section visibility Required: * Minimum of 4+ years of experience in a clinical research setting * Interpersonal skills to effectively communicate information in a timely, professional manner and establish and maintain cooperative and effective working relationships with students, staff, faculty, external collaborators and administration and to work as a member of a team. * Ability to effectively communicate to and interact with patients in a compassionate and kind manner. * Ability to set priorities and complete ongoing tasks with competing deadlines, with frequent interruptions, to meet the programmatic and department needs, while complying with applicable University policies and federal and state regulations. * Analytical skills to assess clinical research protocols and regulatory requirements, define problems, formulate logical solutions, develop alternative solutions, make recommendations, and initiate corrective actions. * Close attention to detail to ensure accuracy in a fast-paced, fluctuating workload environment. * Organization skills to create and maintain administrative and regulatory files effectively as well as independently balance the various tasks to ensure deadlines are met. * Demonstrated proficiency with Adobe and Microsoft suite software, especially Excel, to perform daily tasks efficiently and accurately. * A learning and professional growth mentality so that new software tools, systems, and processes can be adopted quickly and efficiently. * Knowledge of and experience working with a variety of local and external IRBs, scientific review and other research committees, national cooperative group sponsors, industry sponsors, federal and foundation funding organizations, etc. * Strong verbal and written communication skills to effectively establish rapport, building collaborative relationships, and communicate complex concepts and ideas in an easy-to-understand manner. * Ability to adapt to changing job demands and priorities, remain flexible including working flexible hours to accommodate research deadlines. * Ability to handle confidential information with judgement and discretion. * High degree of concentration and focus in a work environment that contains distracting stimuli, competing deadlines, and work delegated by more than one individual. * Availability to work in more than one environment, travelling to various clinic sites, meetings, conferences, etc… * Strong knowledge of and experience working with a variety of local and external IRBs, scientific review and other research committees, national cooperative group sponsors, industry sponsors, federal and foundation funding organizations, etc. * Strong knowledge of clinical research concepts, policies and procedures, and human safety protection regulations and laws. * Ability to think creatively to develop solutions affecting the full team. * Experience with FDA processes and procedures. * Sufficient experience and knowledge of clinical trials budgeting processes to manage the preparation of clinical trials budgets - * Availability to work in more than one environment, travelling to various clinic sites, meetings, conferences, etc. Preferred: * Bachelor's Degree in related area and/or equivalent combination of education and experience. Advanced degree preferred.

Role OverviewThe Clinical Trial Research Scientist evaluates clinical study protocols, trial designs, endpoints, statistical plans, and study results. This role emphasizes methodological rigor, documentation clarity, and accurate interpretation of safety and efficacy outcomes. What You'll Do- Review clinical trial protocols and identify methodological strengths or gaps - Analyze endpoints, inclusion/exclusion criteria, and study controls - Interpret trial results and summarize safety and efficacy findings - Validate statistical analysis plans for completeness and accuracy - Identify operational or scientific risks in trial execution - Support recurring evaluations of clinical documentation and study outputs What You BringMust-Have:- Experience in clinical research, biostatistics, or pharmaceutical science - Strong understanding of trial methodology and regulatory standards - Ability to interpret trial data and communicate findings clearly Nice-to-Have:- Experience with Phase I-IV trials or specific therapeutic areas

General Information Press space or enter keys to toggle section visibility Onsite or Remote Flexible Hybrid Work Schedule Monday - Friday, 8:00am - 5:00pm Posted Date 12/03/2025 Salary Range: $82705.68 - 133068.24 Annually Employment Type 2 - Staff: Career Duration Indefinite Job # 27681 Primary Duties and Responsibilities Press space or enter keys to toggle section visibility The Senior Clinical Research Coordinator plays a critical role in the overall operational management of clinical research/trial/study activities from design, set up, conduct, through closeout. The ideal candidate is an experienced professional or leader who has direct responsibility for the implementation of research activities for one or more studies which may include multicenter clinical trials (both NIH and industry-sponsored), local investigator-initiated clinical trials, and/or programmatic clinical research activities. Recognize and perform necessary project management tasks and prioritizes work to reach scheduled goals. The Senior Clinical Research Coordinator is a technical leader responsible for ensuring the study protocol and procedures have been completed accurately, safely, and in a timely manner. This position may supervise and train others on projects as necessary. Work with PIs, departments, sponsors, institutions, and other entities as needed to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of studies. Annual salary range: $86,849.29 - $139,713.11 Job Qualifications Press space or enter keys to toggle section visibility Required: * Minimum of 4+ years of experience in a clinical research setting * Interpersonal skills to effectively communicate information in a timely, professional manner and establish and maintain cooperative and effective working relationships with students, staff, faculty, external collaborators and administration and to work as a member of a team. * Ability to effectively communicate to and interact with patients in a compassionate and kind manner. * Ability to set priorities and complete ongoing tasks with competing deadlines, with frequent interruptions, to meet the programmatic and department needs, while complying with applicable University policies and federal and state regulations. * Analytical skills to assess clinical research protocols and regulatory requirements, define problems, formulate logical solutions, develop alternative solutions, make recommendations, and initiate corrective actions. * Close attention to detail to ensure accuracy in a fast-paced, fluctuating workload environment. * Organization skills to create and maintain administrative and regulatory files effectively as well as independently balance the various tasks to ensure deadlines are met. * Demonstrated proficiency with Adobe and Microsoft suite software, especially Excel, to perform daily tasks efficiently and accurately. * A learning and professional growth mentality so that new software tools, systems, and processes can be adopted quickly and efficiently. * Knowledge of and experience working with a variety of local and external IRBs, scientific review and other research committees, national cooperative group sponsors, industry sponsors, federal and foundation funding organizations, etc. * Strong verbal and written communication skills to effectively establish rapport, building collaborative relationships, and communicate complex concepts and ideas in an easy-to-understand manner. * Ability to adapt to changing job demands and priorities, remain flexible including working flexible hours to accommodate research deadlines. * Ability to handle confidential information with judgement and discretion. * High degree of concentration and focus in a work environment that contains distracting stimuli, competing deadlines, and work delegated by more than one individual. * Availability to work in more than one environment, travelling to various clinic sites, meetings, conferences, etc… * Strong knowledge of and experience working with a variety of local and external IRBs, scientific review and other research committees, national cooperative group sponsors, industry sponsors, federal and foundation funding organizations, etc. * Strong knowledge of clinical research concepts, policies and procedures, and human safety protection regulations and laws. * Ability to think creatively to develop solutions affecting the full team. * Experience with FDA processes and procedures. * Sufficient experience and knowledge of clinical trials budgeting processes to manage the preparation of clinical trials budgets - * Availability to work in more than one environment, travelling to various clinic sites, meetings, conferences, etc. Preferred: * Bachelor's Degree in related area and/or equivalent combination of education and experience. Advanced degree preferred.

**Job Summary and Responsibilities** The Clinical Research Coordinator (CRC) works with the Principal Investigators, co- and sub-investigators, Senior Clinical Research Coordinator, clinical and ancillary departments, IRBs, and industry or government sponsors of research to support the planning, implementation and coordination of clinical trials and other research projects managed by the CommonSpirit Health Research Institute. Duties may vary depending on the size and complexity of each study. This role assists with clinical trial or other research project coordination duties as assigned, including but not limited to: research participant recruitment, screening and enrollment; completion of protocol required visits and procedures; collection and reporting of data; coordination of and participation in sponsor monitoring visits or federal audits; query resolution; adverse event reporting, source documentation and research record development and maintenance; study drug accountability; specimen collection, processing and shipment. The incumbent helps to ensure compliance of the research program and its studies with all applicable federal and state regulations, as well as CommonSpirit Health policy. This position is responsible for maintaining quality standards for responsive service and professional documentation in compliance with CommonSpirit Health policies and procedures, and federal and state laws and regulations, all which is consistent with the Mission and Values of CommonSpirit Health. Responsibilities and Essential Functions: + Coordinate and participate in site initiation and other sponsor-required training for all protocols. + Dispense study medication to research participants under the direction of the PI, and/or coordinate study drug administration with hospital/clinic Pharmacy staff. + Process labs for clinical trials, including collecting, centrifuging and aliquoting specimens, and ship specimens in accordance with federal biologics shipping regulations. + Conduct informed consent process with research participants; document informed consent discussion and obtain signatures per protocol, federal, state and institutional requirements. + Coordinate all study-required visits, procedures, tests and activities to meet protocol requirements; schedule participant appointments with appropriate provider/facility. + Perform timely and accurate collection and reporting of data in accordance with protocol and sponsor requirements, applicable laws, and institutional policies. + Identify and report all unanticipated and other adverse/serious adverse events, as well as protocol deviations, violations or exceptions, to the study sponsor and IRB as required by GCP, FDA, OHRP and CommonSpirit Health policy. + Serve as liaison between participants, physician investigators, sponsors of research, IRBs, CSHRI administration, patient care coordinators and insurance companies to assist in protocol interpretation, clinical and safety questions, and pre-authorization questions. + Work with CSHRI billing staff to ensure clinical trials are performed in accordance with CommonSpirit Health requirements; complete Research Encounter Forms for all participant visits. **Job Requirements** **Required Education and Experience** + Bachelors in a science or related field. A combination of education and/or additional job-related experience in lieu of the degree. + 3 years of experience conducting clinical trials required; worked as primary research coordinator for at least 5 drug or device trials. + 3 years of experience interacting with patients in a healthcare setting + Experience using electronic data capture software and Clinical Trial Management Systems + Certified Clinical Research Professional (CCRP), within 12 - months or + Certified Clinical Research Coordinator ACRP (CCRC-ACRP) within 12 - months or + Certified Clinical Rearch Coordinator SCRA (CCRC-SCRA) within 12 - months or + Certified Phlebotomy Technician (ANCC) **Where You'll Work** Inspired by faith. Driven by innovation. Powered by humankindness. CommonSpirit Health is building a healthier future for all through its integrated health services. As one of the nation's largest nonprofit Catholic healthcare organizations, CommonSpirit Health delivers more than 20 million patient encounters annually through more than 2,300 clinics, care sites and 137 hospital-based locations, in addition to its home-based services and virtual care offerings. CommonSpirit has more than 157,000 employees, 45,000 nurses and 25,000 physicians and advanced practice providers across 24 states and contributes more than $4.2 billion annually in charity care, community benefits and unreimbursed government programs. Together with our patients, physicians, partners, and communities, we are creating a more just, equitable, and innovative healthcare delivery system. **Pay Range** $36.00 - $48.69 /hour We are an equal opportunity employer.

Care Access is working to make the future of health better for all. With hundreds of research locations, mobile clinics, and clinicians across the globe, we bring world-class research and health services directly into communities that often face barriers to care. We are dedicated to ensuring that every person has the opportunity to understand their health, access the care they need, and contribute to the medical breakthroughs of tomorrow. With programs like Future of Medicine, which makes advanced health screenings and research opportunities accessible to communities worldwide, and Difference Makers, which supports local leaders to expand their community health and wellbeing efforts, we put people at the heart of medical progress. Through partnerships, technology, and perseverance, we are reimagining how clinical research and health services reach the world. Together, we are building a future of health that is better and more accessible for all. To learn more about Care Access, visit ******************* How This Role Makes A Difference The Travel Clinical Research Assistant is an entry level clinical position and is designed to fully integrate the individual in the Care Access Research process while learning the skills necessary to be a Clinical Research Coordinator. This position has potential growth and advancement within the Care Access Research organization. This position is for a full-time temporary, hourly role. The duration is 12-months from the decision to hire. This role will perform a variety of clinical and administrative tasks in support of clinical trials and assist in the performance of clinical procedures to collect data on patients enrolled and/or seeking enrollment in clinical studies. Much of the work for this role will be done onsite at a clinical event or site location. How You'll Make An Impact * Perform independent venipuncture; manage difficult draws and re-attempts per protocol. * Collect, label, process, package, and ship biospecimens; maintain chain of custody and temperature controls. * Set up/tear down event sites; prepare kits/supplies; uphold aseptic technique and biohazard safety. * Communicate clearly with participants and on-site teams; escalate issues promptly. * Ability to understand and follow institutional SOPs. * Participate in recruitment and pre-screening events (may be multiple locations). * Assist with preparation of outreach materials. * Request medical records of potential and current research participants. * Schedule visits with participants, contact with reminders. * Obtain informed consent per Care Access Research SOP, under the direction of the Clinical Research Coordinator (CRC). * Complete visit procedures as required by protocol, under the direction of the CRC. * Record data legibly and enter in real time on paper or e-source documents. * Request and issue study participant payments. * Update all applicable internal trackers and online recruitment systems. * Assist with administrative tasks such as copying, scanning, filing, mailing, emailing, etc. * Assist with maintaining all site logs. * Assist with inventory and ordering equipment and supplies. * Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials. * Maintain effective relationships with study participants and other Ccare Access Research personnel. * Interact in a positive, professional manner with patients/participants, sponsor representatives, Investigators and Care Access Research personnel and management. * Communicate clearly verbally and in writing. * Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive. The Expertise Required * Ability and willingness to work independently with minimal supervision. * Ability to learn to work in a fast-paced environment. * Excellent communication skills and a high degree of professionalism with all types of people * Excellent organizational skills with strong attention to detail * A working knowledge of medical and research terminology * A working knowledge of federal regulations, Good Clinical Practices (GCP) * Critical thinker and problem solver * Friendly, outgoing personality with the ability to maintain a positive attitude under pressure. * Contribute to team and site goals. * Proficiency in Microsoft Office Suite * High level of self-motivation and energy * An optimistic, "can do" attitude. Certifications/Licenses, Education, and Experience: * 1+ year recent hands-on phlebotomy experience in a clinical setting. * ≥200 total venipunctures; ≥25-50 capillary sticks; ≥30-50 sticks in the last 2-3 months. * Some Clinical Research experience preferred. * Demonstrated competency in specimen processing. * Working knowledge of ICH-GCP, basic research terminology, and HIPAA/PHI handling. * Comfortable using mobile apps/eSource and standard office tools. * Current national phlebotomy certification (one of): * ASCP Phlebotomy Technician (PBT) * AMT Registered Phlebotomy Technician (RPT) * NHA Certified Phlebotomy Technician (CPT) * NCCT National Certified Phlebotomy Technician (NCPT) * CA/WA/LA/NV specific licensure/certification if role is based there How We Work Together * Location: Candidates must be willing to travel in support of community events within your metropolitan area and occasional national travel. * Travel: Duties may require travel in the following models: * Tuesday through Saturday Work Weeks * Temporary Event Support (3-7-day deployment durations) * Frequency and length of travel may depend on the length and location of study, site, and event. * Deployments normalize to a 32 to 42-hour work week on average. The expected salary range for this role is $24.00 - $38.00 USD per hour. In addition to base pay, employees may be eligible for 401k, stock options, health and wellness benefits and paid time off. Diversity & Inclusion We work with and serve people from diverse cultures and communities around the world. We are stronger and better when we build a team representing the communities we support. We maintain an inclusive culture where people from a broad range of backgrounds feel valued and respected as they contribute to our mission. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to, and will not be discriminated against on the basis of, race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. Care Access is unable to sponsor work visas at this time. If you need an accommodation to apply for a role with Care Access, please reach out to: ********************************

Site: The McLean Hospital Corporation Mass General Brigham relies on a wide range of professionals, including doctors, nurses, business people, tech experts, researchers, and systems analysts to advance our mission. As a not-for-profit, we support patient care, research, teaching, and community service, striving to provide exceptional care. We believe that high-performing teams drive groundbreaking medical discoveries and invite all applicants to join us and experience what it means to be part of Mass General Brigham. The Brain Stimulation Mechanisms Laboratory (BSML) is seeking a self-motivated applicant to join the Transcranial Magnetic Stimulation Research (TMS) Program in the Division of Depression and Anxiety Disorders at McLean Hospital. We aim to understand the neural mechanisms of non-invasive brain stimulation including Transcranial Magnetic Stimulation (TMS), and to leverage this knowledge to improve clinical effectiveness. Job Summary Job Profile Summary Summary Working under the supervision of a Senior Research Assistant, Manager or Principal Investigator and following established policies and procedures, provides assistance on clinical research studies. Supervisor available to handle unusual situations and regularly reviews progress of work. Does this position require Patient Care? No Essential Functions -Collects and organizes patient data. -Maintains records and databases. -Uses software programs to generate graphs and reports. -Recruiting patients for clinical trials, conducts phone interviews and schedules patients for visits. -Obtains patient study data from medical records, physicians, etc. -Conducts library searches. -Performs administrative support duties as required. -Verifies accuracy of study forms. -Updates study forms per protocol. -Prepares data for analysis and data entry. -Assists with formal audits of data. -Documents patient visits and procedures. -Assists with regulatory binders and QA/QC procedures. -Assists with interviewing study subjects. -Administers and scores questionnaires. -Provides basic explanation of study and in some cases obtains informed consent from subjects. -Performs study procedures such as phlebotomy. -Assists with study regulatory submissions. -Writes consent forms. -Verifies subject inclusion/exclusion criteria. Qualifications Job Description Education Bachelor's Degree required Can this role accept experience in lieu of a degree? No Licenses and Credentials Experience Related experience 0-1 year Knowledge, Skills and Abilities - Careful attention to details. - Good organizational skills. - Ability to follow directions. - Good interpersonal and communication skills. - All employees must possess basic computer skills to use a variety of electronic or online systems for communication, clinical and administrative purposes. - Working knowledge of clinical research protocols. - Ability to demonstrate respect and professionalism for subjects' rights and individual needs. - Works independently under close supervision. Additional Job Details (if applicable) Remote Type Onsite Work Location 115 Mill Street Scheduled Weekly Hours 40 Employee Type Regular Work Shift Day (United States of America) Pay Range $19.76 - $37.12/Hourly Grade MRA500 At Mass General Brigham, we believe in recognizing and rewarding the unique value each team member brings to our organization. Our approach to determining base pay is comprehensive, and any offer extended will take into account your skills, relevant experience if applicable, education, certifications and other essential factors. The base pay information provided offers an estimate based on the minimum job qualifications; however, it does not encompass all elements contributing to your total compensation package. In addition to competitive base pay, we offer comprehensive benefits, career advancement opportunities, differentials, premiums and bonuses as applicable and recognition programs designed to celebrate your contributions and support your professional growth. We invite you to apply, and our Talent Acquisition team will provide an overview of your potential compensation and benefits package. EEO Statement: The McLean Hospital Corporation is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religious creed, national origin, sex, age, gender identity, disability, sexual orientation, military service, genetic information, and/or other status protected under law. We will ensure that all individuals with a disability are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. To ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Veteran's Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact Human Resources at **************. Mass General Brigham Competency Framework At Mass General Brigham, our competency framework defines what effective leadership “looks like” by specifying which behaviors are most critical for successful performance at each job level. The framework is comprised of ten competencies (half People-Focused, half Performance-Focused) and are defined by observable and measurable skills and behaviors that contribute to workplace effectiveness and career success. These competencies are used to evaluate performance, make hiring decisions, identify development needs, mobilize employees across our system, and establish a strong talent pipeline.

Job Description Apply Here: ******************************************************************************* Come and join our team! We are a local growing private medical practice specializing in the diagnosis and treatment of patients with diseases of the retina and vitreous. We are looking for individuals who would like to establish a career in healthcare working with nationally recognized physicians. We provide on the job training giving you the ability to grow and advance your skills along with gaining innovative knowledge. Established in 1977, we have locations all over Northern California including Sacramento, Grass Valley, Roseville, Stockton, Modesto, Merced, Fairfield, Elk Grove, Folsom, Yuba City and Chico. Our physicians are nationally known, and we continue to be on the leading edge of retina care by utilizing the latest equipment and both participating in and designing new clinical trials to advance the state of care for retinal diseases. Join 250+ other team members working for our nationally recognized retina specialty practice in a fast paced, high volume medical office. We are currently participating in several trials at two of our office locations and have a growing clinical research department. The research assistant is primarily responsible for assisting in research patient visits according to ICH-GCP guidelines and according to the IRB-approved study protocol and/or manual of procedures. Day-to-day activities may include all or some of the essential functions listed below, depending upon individual experience / knowledge and the needs of the organization which are subject to change from time to time. We seek a full-time clinical research assistant to support our clinical research department. Although you must be able to work independently, you will be working directly with physicians, patients, research coordinators, clinical and business office staff and with pharmaceutical sponsor representatives to correctly and efficiently execute clinical research protocols. Collaboration and being a team player are essential to the success of this role. Responsibilities Coordinate and schedule subject visits within study/subject specific windows per protocol guidelines. Prepare visit-specific documentation and charts for Clinical Research Coordinator Observe Coordinator in patient care and management Assist Coordinator in monitoring subject flow and assist in subject care and management Observe, assist, collect and record all necessary data for follow up Transcribe subject study information from source documents to the Electronic Case Report Forms Administer all mandatory questionnaires to study subjects Set up, prepare subject, and conduct electrocardiograms (ECG) on subjects as required per study protocol Promptly request all necessary medical records for Serious Adverse Event Reporting Process and ship laboratory biological samples for analysis Perform intraocular pressure checks after injections Perform trial frame refraction and visual acuity testing Perform other duties as assigned

Clinical Research Assistant I - (10032367) Description Join the forefront of groundbreaking research at the City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. Our dedicated and compassionate faculty and staff are driven by a common mission: Contribute to innovative approaches in predicting, preventing, and curing diseases, shaping the future of medicine through cutting-edge research. Exciting opportunity for a detail-oriented individual! Join us as a Clinical Research Assistant I in which you will manage an assigned set of multiple research protocols to assure efficiency and regulatory compliance of the protocol. As a successful candidate, you will:Conduct protocol management for an assigned set of multiple research protocols. Maintain current and accurate protocol documentation and notify investigators of pertinent protocol changes. Ensure participants are appropriately registered and maintain documentation of participant registration. Compile and submit data on appropriate forms according to protocol requirements. Ensure protocol compliance through intense monitoring of specific study requirements and schedule protocol-related activities. Play an active role in the recruitment of participants for the study. Assist in training and mentoring new clinical research staff members. Perform protocol-specific clinical duties as required by the research study. Perform data management and data analyses as required by the research study. Establish and maintain interpersonal relationships with participants, visitors, and other hospital personnel while ensuring the confidentiality of participant information. Collect and deliver specimens for analysis using appropriate equipment for collecting and handling specimens, ensure proper labeling, and obtain pertinent clinical and protocol information on request forms. Develop and maintain knowledge of various aspects of processing specimens, with particular attention to safety practices. Identify and communicate important protocol and data management issues or problem areas to the supervisor. Qualifications Your qualifications should include:Associate's Degree. Experience may substitute for minimum education requirements. Read, identify and extract pertinent data from medical records. Ability to read, write and comprehend medical terminology. Medical Record, Health Information Systems, or related health field. Preferred qualifications:Bachelor's degree. Bilingual/Biliterate English/Spanish for regular written and verbal communications in Spanish with research participants and collaborating investigators. Experience with Progeny preferred. City of Hope employees pay is based on the following criteria: work experience, qualifications, and work location. City of Hope is an equal opportunity employer. To learn more about our Comprehensive Benefits, please CLICK HERE. Primary Location: United States-California-DuarteJob: Population SciencesWork Force Type: OnsiteShift: DaysJob Posting: Oct 11, 2025Minimum Hourly Rate ($): 33. 000000Maximum Hourly Rate ($): 36. 781100

Job DescriptionMatrix Clinical Research is a leading organization in the field of clinical research, dedicated to advancing medical knowledge and improving patient outcomes. We conduct cutting-edge research studies in various therapeutic areas, and we are looking for a dedicated Clinical Research Medical Assistant to join our dynamic team. Job Summary: The Clinical Research Medical Assistant will assist in the conduct of clinical trials by providing support to the clinical research team, ensuring the safety and well-being of study participants, and maintaining the integrity of study data. The ideal candidate is a detail-oriented professional with a passion for clinical research and patient care. Key Responsibilities: Assist in the recruitment, screening, and enrollment of study participants. Perform vital signs, ECGs, phlebotomy, and other clinical procedures as required by study protocols. Collect and process biological samples (e.g., blood, urine) for laboratory analysis. Document patient visits and study procedures accurately in electronic medical records and case report forms. Schedule and coordinate study visits and follow-ups. Educate study participants about study protocols, procedures, and consent forms. Monitor and report any adverse events or protocol deviations to the study coordinator. Maintain inventory of study supplies and ensure that all equipment is in good working order. Assist with data entry, filing, and organization of study documents. Comply with Good Clinical Practice (GCP) guidelines and company SOPs. Work collaboratively with the research team to ensure the smooth running of clinical trials. Qualifications: Certified Medical Assistant (CMA) or equivalent certification. Experience in a clinical research setting preferred. Knowledge of medical terminology and clinical procedures. Strong organizational and time-management skills. Excellent communication and interpersonal skills. Ability to work independently and as part of a team. Proficient in Microsoft Office and electronic medical records systems. CPR certification required. Benefits: Competitive salary and benefits package. Opportunities for professional development and growth. Collaborative and supportive work environment. Contribution to impactful clinical research that improves patient lives.

Title: Part time Clinical Research assistant The Research Assistant I provides direct support to Clinical Research Coordinators in the completion of protocol-specific study goals while observing strict adherence to ICH, GCP, protocol, and site guidelines and policies. Essential Responsibilities and Duties: • Creating and maintaining patient charts for all assigned studies. • Preparing participant visits based on CRCs schedule, ensuring all source documents, assessments, lab kits and other visit materials are available and accurate. Filing of lab results, EKG results, and other communication in designated patient charts. • Maintaining inventory of study specific supplies including lab kits, assessments and participant facing materials. • Timely completion of data entry and query resolution for all CRFs, based on sponsor specific timelines and deadlines established in contract or other communication. • Assisting Coordinators in assessments, blood pressure, urine collection, draw labs • Communicating with study participants, caregivers, third party vendors and laboratories as needed. • Assisting Coordinators with scheduling, copying, faxing, and other clerical tasks. • Aiding Coordinators in the facilitation of study monitoring visits. • Completion of daily responsibilities delegated by CRC as they pertain to the study and/or participants. • Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive. • Office/administrative tasks assigned ie: resupplying exam rooms, ordering office supplies, answering phone calls, etc. Education/Experience/Skills: • High school graduate or equivalent. Bac • Excellent computer skills and advanced knowledge of electronic equipment (i.e., e-mail, computer, fax machine, copier, etc.). • Skilled in organization and record maintenance. • Strong personal initiative and attention to detail. • Ability to clearly communicate both orally and verbally. • Prior experience in healthcare, research, or clinical settings is a plus. • Basic knowledge of clinical research processes and regulations (GCP, FDA, IRB) is a plus.

Velocity Clinical Research is an owned and integrated research site organization, providing excellence in patient care, high quality data and fully integrated research sites. At Velocity, we align our values and behaviors to give our employees the best chance of delivering on our brand promise: to bring innovative medical treatments to patients. We are committed to making clinical trials succeed by generating high quality data from as many patients as possible, as quickly as possible while providing exemplary patient care at every step. As an employee of Velocity, you are the most integral part of our mission. For talented candidates who perform at a high level, Velocity will invest to support career advancement and reward performance. Whether you are new to clinical research or are an industry veteran, we invite you to apply to Velocity. Benefits include medical, dental and vision insurance, paid time off and company holidays, 401(k) retirement plan with company-match, and an annual incentive program. Summary: The Clinical Research Assistant assists the Clinical Operations Team in a multi-functional capacity to carry out all assigned tasks associated with the collection, documentation, and maintenance of clinical data including phlebotomy/laboratory, data entry and administrative responsibilities. Responsibilities Duties/Responsibilities: Assist in the conduct of clinical trials in accordance with the study protocol, GCP, ICH Guidelines, and Velocity's SOPs Perform venipuncture, capillary puncture and/or other fluid collection within scope of the protocol and local law and regulations With supervision, perform clinical assessments (vital signs, phlebotomy, ECG, etc) within scope of the protocol, local law and regulations Process, package and ship laboratory specimens as required per protocol and IATA regulations, if applicable Track, order and maintain inventory of all laboratory and study related supplies throughout course of the clinical trial Enter source data into the sponsor's and/or vendor's data portal and resolve basic queries in a timely manner under the direction of the Clinical Research Coordinator Communicate with coworkers, leadership, study subjects, sponsors, CROs, and vendors under the direction of the Clinical Research Team Understand good documentation practices when collecting, transferring data to sponsor/CRO data capture systems and resolving queries under the direction of the Clinical Research Coordinator Understand the informed consent process with emphasis on ensuring initial and ongoing consent of study subjects Understand basic elements of regulatory documentation required to initiate, maintain and close a clinical research trial Understand and participate in patient recruiting tasks including but not limited to prescreening potential subjects for clinical research trials either via phone or in person Maintain confidentiality of patient protected health information, sponsor confidential information and Velocity confidential information Ability to escalate potential patient safety issues such as adverse events, serious adverse events, and adverse events of special interest to the Clinical Research Team Cleaning, organizing, and disinfecting the patient care, lab and lab equipment areas as needed Prepare source document charts, copy and/or file medical records and study related documents as required. Perform front office duties as needed including but not limited to answering phones, scheduling subjects, making reminder calls and updating patient tracking systems. Other duties as assigned Qualifications Education/Experience: High School Graduate and/or technical degree with minimum of 1 year of relevant experience in life sciences industry Required Licenses/Certifications: Phlebotomy if applicable and required by state law Intramuscular dose administration and preparation if applicable and required by state law Required Skills: Demonstrated knowledge of medical terminology Demonstrated ability to use the following technology: Computers, Microsoft Office software, fax, copier, and multi-line telephone. Understanding of verbal, written, and organizational skills Demonstrated ability to work as a team player Demonstrated ability to read, write, and speak English Demonstrated ability to multi-task Demonstrated ability to follow written guidelines Demonstrated ability to be flexible/adapt as daily schedule may change rapidly Required Physical Abilities: Sit or stand for long periods of time Communicate in person and by a telephone Limited walking required Limited to lifting up to 30 pounds NOTE: The above Job Description is intended to communicate the general function of the mentioned position and by no means should be considered an exhaustive or complete outline of the specific tasks and functions that will be required. Additionally, specific tasks and duties of the position are subject to change as the Company, the department and circumstances change. All employees are expected to perform their duties within their ability as required by the job and/or as requested by management. Compensation Approximate range $20.00-26.00/hour. The base pay offered will be determined based on relevant factors such as experience, education, and geographic location.

Primary Duties and Responsibilities: * Prepare and submit research protocols, consent forms, recruitment materials, and IRB applications for human subjects' approval. * Submit internal documentation for contract execution and maintain communication with contracting officers and sponsors during budgeting and negotiation. * Develop research project budgets based on protocol requirements and published research costs, ensuring consistency across protocol, budget, and informed consent documents. * Monitor study payments and generate invoices to ensure adequate funding throughout the trial. * Ensure timely filing of annual renewals and amendment submissions to the IRB. * Maintain accurate and complete regulatory documentation, including consent forms, case report forms, SAE reports, and source documents, in compliance with IRB, FDA, OHRP, HIPAA, and other agency guidelines. * Keep regulatory files up to date (training records, financial disclosures, FDA forms, CVs, licenses, etc.). * Complete IRB paperwork and submit internal and external Serious Adverse Events (SAEs) and IND Safety Reports as required. * Assist with coordination and preparation for institutional, pharmaceutical, and internal audits. * Organize site feasibility and initiation visits, including completion of feasibility questionnaires. * Provide facility tours for sponsors, CROs, and other research-related visitors. * Collaborate with internal and external investigators and participating centers in multi-center studies. * Participate in weekly research staff meetings. * Protect the rights and confidentiality of research participants, ensuring proper consent and HIPAA compliance. * Perform administrative duties as assigned in a timely manner. Requirements: * Education: High School Diploma or GED required. * Experience: Minimum of 1 year of clinical research-related experience required. (*This is NOT a lab based role*) Job Type & Location This is a Contract to Hire position based out of Los Angeles, CA. Pay and Benefits The pay range for this position is $20.00 - $22.00/hr. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan - Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Los Angeles,CA. Application Deadline This position is anticipated to close on Dec 31, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

ABOUT US Each of CenExel's research sites specialize in Phase I to Phase IV clinical trials. Our Centers of Excellence comprise some of the most well respected and long-standing research facilities in the country. Specialty areas of research across our sites include Psychiatry, Acute Post Op Pain, Asian Bridging, Dermatology, GI, and Neurology. Each of our Centers of Excellence has tremendous experience and expertise in complex early phase trials, and all our sites have in-patient capability. We focus on quality people, teamwork, and highly experienced clinical research managers with a history of success. Along with an exceptional work environment that promotes teamwork, positive leadership, and optimal work-life balance, CenExel Clinical Research also provides highly competitive compensation and a generous benefits package to full time employees after 30 days of employment including Health Insurance, Dental, Vision, LTD, STD, Life Ins, and 401k. HOURLY RANGE: $20.00 - $21.00 (Depending on education, experience, and skillset.) Schedule: Monday - Friday 8:00 am - 4:30 pm + Occasional Saturdays Job Summary: Provides direct support to Clinical Research Coordinators in the completion of protocol-specific study goals while observing strict adherence to ICH, GCP, protocol, and site guidelines and policies. Essential Responsibilities and Duties: Creating and maintaining patient charts for all assigned studies. Maintaining inventory of study-specific supplies, including lab kits, assessments, and participant-facing materials. Timely completion of data entry and query resolution for all CRFs, based on sponsor-specific timelines and deadlines established in contract or other communication. Assisting Coordinators in assessments, including but not limited to blood pressure, urine collection. Communicating with study participants, caregivers, third-party vendors, and laboratories as needed. Assisting Coordinators with scheduling, copying, faxing, and other clerical tasks. Aiding Coordinators in the facilitation of study monitoring visits. Completion of daily responsibilities delegated by CRC as they pertain to the study and/or participants. Assumes other duties and responsibilities as assigned. The above responsibilities are a general description of the level and nature of the work assigned to this classification and are not to be considered as all inclusive. Education/Experience/Skills: Interest in and knowledge of specific study indications. Excellent computer skills and advanced knowledge of electronic equipment (i.e., e-mail, computer, fax machine, copier, etc.). Skilled in organization and record maintenance. Skilled in developing and maintaining effective working relationships with supervisors and co- workers. Strong personal initiative and attention to detail. Ability to react calmly and effectively in emergency situations. Ability to interpret, adapt and apply guidelines and procedures. Ability to clearly communicate both orally and verbally. Working Conditions Indoor, Office environment. Essential physical requirements include sitting, typing, standing, and walking. Lightly active position, occasional lifting of up to 20 pounds. Reporting to work, as scheduled, is essential. CenExel Clinical Research is an Equal Opportunity Employer. All applicants will be considered for employment without regards to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran, or status.